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Found 20465 cases where Vaccine is PNC13

Case Details (Reverse Sorted by Appearance Date)

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VAERS ID:660182 (history)  Vaccinated:2016-09-21
Age:80.0  Onset:2016-09-22, Days after vaccination: 1
Gender:Female  Submitted:2016-10-18, Days after onset: 26
Location:Florida  Entered:2016-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Hydrochlorothiazide 25mg, metoprolol ext rel 50 mg, magnesium over the counter
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: The center did blood work and a physical.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHN165620IMLA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Erythema, Feeling cold, Pain in extremity, Rash macular, Somnolence
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Patient felt drowsy and had chills, joints were achy and legs achy, began feeling better the next day, Saturday the 24th she developed small red spots on her leg. Described as small round blotches like a "rash".

VAERS ID:660216 (history)  Vaccinated:2016-10-10
Age:75.0  Onset:2016-10-15, Days after vaccination: 5
Gender:Female  Submitted:2016-10-18, Days after onset: 3
Location:Florida  Entered:2016-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lisinopril 5mg
Current Illness: n/a
Preexisting Conditions: Hypertension
Diagnostic Lab Data: n/a
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHM130670IMLA
Administered by: Other     Purchased by: Private
Symptoms: Hypersensitivity, Injection site reaction
SMQs:, Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Mild localized injection site reaction appearing to be allergic in nature. Treated with cold compress and Benadryl.

VAERS ID:660222 (history)  Vaccinated:2016-10-15
Age:80.0  Onset:2016-10-18, Days after vaccination: 3
Gender:Female  Submitted:2016-10-18, Days after onset: 0
Location:Texas  Entered:2016-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHN16515 IMRA
Administered by: Other     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Reaction to Prevnar 13. Rash, redness and hardness to a large area of the right upper arm.

VAERS ID:660225 (history)  Vaccinated:2016-10-18
Age:70.0  Onset:2016-10-18, Days after vaccination: 0
Gender:Female  Submitted:2016-10-18, Days after onset: 0
Location:Wisconsin  Entered:2016-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Not known.
Current Illness: None
Preexisting Conditions: Allergic to aspirin and codeine
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHM069000IMRA
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Immediate swelling at injection site. Patient was feeling fine, no problems breathing, no rash. Rph applied cold compress and the sweeling decreased.

VAERS ID:662304 (history)  Vaccinated:2016-10-17
Age:0.25  Onset:2016-10-18, Days after vaccination: 1
Gender:Female  Submitted:2016-10-18, Days after onset: 0
Location:Georgia  Entered:2016-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.M0201620UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHN349350UNRL
Administered by: Private     Purchased by: Private
Symptoms: Pain, Pyrexia, Vaccination site erythema, Vaccination site induration
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 2 cm area of erythema and induration of both thighs at site of vaccine. Rx: TYLENOL 80 mg po Q6 hrs prn pain/fever.

VAERS ID:663126 (history)  Vaccinated:2016-10-12
Age:1.0  Onset:2016-10-13, Days after vaccination: 1
Gender:Female  Submitted:2016-10-18, Days after onset: 5
Location:Texas  Entered:2016-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSKT54C UNRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUI552AA UNRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.L041456 UNRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHM98916 UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.M006722 UNLL
Administered by: Private     Purchased by: Unknown
Symptoms: Irritability, Pyrexia, Rash maculo-papular
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Child developed generalized Maculopapular rash, low grade fever and has irritable.

VAERS ID:663128 (history)  Vaccinated:2016-10-07
Age:0.5  Onset:2016-10-07, Days after vaccination: 0
Gender:Male  Submitted:2016-10-10, Days after onset: 3
Location:Delaware  Entered:2016-10-18, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Steroid cream as needed eczema flairs
Current Illness: No
Preexisting Conditions: Eczema; Followed by allergist for allergy milk, eggs, peanuts
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC5069AC2IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHN165622IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.M0047262PO 
Administered by: Private     Purchased by: Private
Symptoms: Cough, Dyspnoea, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: 6 month old male received PENTACEL, PREVNAR and ROTA (had received and done well with same vaccines at 2 and 4 months of age) child with eczema and allergy to egg, milk, peanut. Child went home and within hour after vaccines started with cough, wheezing, increased work of breathing.

VAERS ID:663181 (history)  Vaccinated:2016-10-05
Age:65.0  Onset:2016-10-07, Days after vaccination: 2
Gender:Female  Submitted:2016-10-12, Days after onset: 5
Location:Washington  Entered:2016-10-18, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHN165150IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness, soreness, warmth on upper 1/2 of injection arm.

VAERS ID:663361 (history)  Vaccinated:2016-01-14
Age:79.0  Onset:2016-01-15, Days after vaccination: 1
Gender:Female  Submitted:2016-10-10, Days after onset: 268
Location:Connecticut  Entered:2016-10-18, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Several
Current Illness: None
Preexisting Conditions: No
Diagnostic Lab Data: Biopsy Oct 7, 2016. Result: Cells are either Lyme disease or external deug. Lyme disease negative.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHM16258 UNUN
Administered by: Private     Purchased by: Other
Symptoms: Biopsy, Borrelia test negative, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Severe rash within 24 hours of injection. Rash continues as of this date. Patient seen by 4 doctors. Latest dermatologist said PREVNAR 13. Triamcinolone acetonide cream prescribed 10/7. Itching subsided. Rash continues to appear.

VAERS ID:663556 (history)  Vaccinated:2016-10-14
Age:65.0  Onset:2016-10-16, Days after vaccination: 2
Gender:Female  Submitted:2016-10-18, Days after onset: 2
Location:Florida  Entered:2016-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHN165621IMUN
Administered by: Other     Purchased by: Unknown
Symptoms: Erythema, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Saturday morning woke up with extreme pain and swelling and redness, iced arm Saturday and Sunday and went to doctor Monday afternoon given antibiotic if not better by Thursday pt had to return.

VAERS ID:659987 (history)  Vaccinated:2016-07-07
Age:1.0  Onset:2016-08-13, Days after vaccination: 37
Gender:Female  Submitted:2016-10-18, Days after onset: 66
Location:Foreign  Entered:2016-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Test Name: Thrombocyte count; Result Unstructured Data: Test Result: 18,000; Test Name: Thrombocyte count; Result Unstructured Data: Test Result: 16,000; Test Name: Thrombocyte count; Result Unstructured Data: Test Result: 45,000; Test Name: Thrombocyte count; Result Unstructured Data: Test Result: additional decrease in platelets; Test Name: Thrombocyte count; Result Unstructured Data: Test Result: increase in platelets; Test Name: Thrombocyte count; Result Unstructured Data: Test Result: 37,000; Test Name: Thrombocyte count; Result Unstructured Data: Test Result: 126,000
CDC Split Type: ILPFIZER INC2016479573
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.  UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHN066912 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Contusion, Diarrhoea, Gingival bleeding, Haematoma, Immune thrombocytopenic purpura, Immunoglobulin therapy, Platelet count decreased, Pyrexia, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gingival disorders (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This is a spontaneous report from a contactable other HCP. This report was received from the Ministry of Health. Regulatory authority report number was not provided. A 12-month-old female patient of an unspecified age and ethnicity received PREVENAR 13, (lot # N066912) at single dose, and PROQUAD at an unspecified dose, both on 07Jul2016 for immunisation. The patient medical history and concomitant medications were not reported. The contactable other HCP reported of a case of Persistent ITP which occurred in proximity to receipt of injections PREVENAR and PROQUAD. Date of diagnosis was 13Aug2016. In 2016, about 5 weeks after vaccine administration, according to the mother, small blue dots and marks of hematomas appeared on limbs. In addition, a few days prior to the hospitalization the baby was bruised from a table in her forehead and afterwards they noticed a hematoma. It is worth noting that 3 weeks prior to the hospitalization the baby experienced fever and diarrhea. On 13Aug2016 she was admitted for the first time with a diagnosis of thrombocytopenia with suspicion of ITP (immune thrombocytopenic purpura), she was treated with 2 courses of IVIG, was released with 18,000 platelets. On 16Aug2016 she arrived for a follow-up at the clinic and due to an additional decrease of platelets (16,000) it was decided of steroids administration in hospitalization, she received treatment during 3 days and an increase in platelets was seen (45,000) she was discharged and continued receiving prednisone at home. After a decrease in platelets, on 23Aug2016 she was hospitalized again for intra-venous steroidal treatment, and again there was an increase in platelets and afterwards there was a decrease, she was discharged with 37,000 platelets and a wider investigation was performed as the ITP was not responding to treatment. On 14Sep (year unspecified) she returned to hospitalization due to new hematomas and bleeding from gums, she was treated with steroids and immunoglobulins with a good response and increase to 126,000 platelets. The baby was under follow up in an hematological clinic.

VAERS ID:659988 (history)  Vaccinated:2016-09-27
Age:0.17  Onset:2016-09-27, Days after vaccination: 0
Gender:Female  Submitted:2016-10-18, Days after onset: 21
Location:Foreign  Entered:2016-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Test Date: 20160929; Test Name: Blood culture; Result Unstructured Data: Test Result: Negative at discharge; Test Date: 20160927; Test Name: Body temperature; Result Unstructured Data: Test Result: 37.6, Test Result Unit: Centigrade; Test Date: 20160927; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 3.61, Test Result Unit: mg/dl; Test Date: 20160929; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 0.7, Test Result Unit: mg/dl; Test Date: 20160927; Test Name: Urine culture; Result Unstructured Data: Test Result: negative; Test Date: 20160927; Test Name: Hematocrit; Test Result: 34 %; Test Date: 20160927; Test Name: Hemoglobin; Result Unstructured Data: Test Result: 11.3, Test Result Unit: g/dl; T
CDC Split Type: ITPFIZER INC2016479413
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME)UNKNOWN MANUFACTURERL03012V0IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHN550900IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood culture negative, Body temperature increased, C-reactive protein increased, Culture urine negative, Haematocrit decreased, Haemoglobin normal, Localised oedema, Petechiae, Platelet count increased, Procalcitonin normal, Red blood cell count normal, Vomiting, White blood cell count normal
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This is a spontaneous report from a contactable physician received from the regulatory authority. The Regulatory authority report number is 378673. A 2 month-old female patient on 27Sep2016 received the first dose of PREVENAR 13, (lot N55090, expiry date 30Sep2018) at 0.5 ml single and the first dose of HEXYON, (lot L03012V, expiry date 30Jun2017) at 1 dosage form (DF) single, both intramuscular for vaccination. The patient medical history and concomitant medications were not reported. On 27Sep2016 the patient experienced local oedema and raised temperature (37.6 C) due to which she was hospitalized. The day after, on 28Sep2016, she had vomiting episodes and petechiae localized on inferior limbs. The patient underwent laboratory tests and procedures which included C-reactive protein at 3.61 mg/dl on 27Sep2016, 0.7 mg/dl on 29Sep2016, culture urine negative on 27Sep2016, haematocrit 34 % on 27Sep2016, haemoglobin 11.3 g/dl on 27Sep2016, platelet count 582000 /mm3 on 27Sep2016, unknown value on 29Sep2016, procalcitonin: 0.1 ng/ml on 27Sep2016, red blood cell count: 3.650.000 /mm3 on 27Sep2016, leukocytes: 11.110 /mm3 on 27Sep2016 and blood culture negative at discharge on 29Sep2016. Therapeutic measures were taken as a result of the events and included treatment with ceftriaxone from 27Sep2016 to 29Sep2016. The patient completely recovered on 29Sep2016 and on the same day she was discharged.

VAERS ID:660043 (history)  Vaccinated:2016-10-04
Age:84.0  Onset:2016-10-06, Days after vaccination: 2
Gender:Female  Submitted:2016-10-18, Days after onset: 12
Location:Foreign  Entered:2016-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CONIEL; CETAPRIL; FRANDOL
Current Illness: Hypertension; Ischaemic heart disease
Preexisting Conditions:
Diagnostic Lab Data: Test Date: 20161008; Test Name: Body temperature; Result Unstructured Data: Test Result: 38.5, Test Result Unit: Centigrade; Test Date: 20161012; Test Name: Body temperature; Result Unstructured Data: Test Result: 36, Test Result Unit: Centigrade; Test Date: 20161012; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 22, Test Result Unit: mg/dl; Test Date: 20161012; Test Name: White blood cell count; Result Unstructured Data: Test Result: 18000, Test Result Unit: /mm3
CDC Split Type: JPPFIZER INC2016474613
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: C-reactive protein increased, Muscular weakness, Myalgia, Pyrexia, Vaccination site pain, Vaccination site swelling, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This is a spontaneous report obtained from a contactable nurse through a Pfizer representative and from a contactable physician. An 84-year-old female patient of an unspecified ethnicity received on 04Oct2016 intramuscular PREVENAR 13 at 0.5 ml single, for immunisation. Ongoing medical history included hypertension and suspected ischaemic heart disease. Concomitant medications included oral CONIEL 4 mg, daily, oral CETAPRIL 25 mg, daily and oral FRANDOL 80 mg, daily, all ongoing for underlying diseases. The patient experienced vaccination site pain and vaccination site swelling (from deltoid muscle of upper arm to whole upper arm) on 06Oct2016, pyrexia (at 38.5 degrees) on 08Oct2016, myalgia (upper extremities and lower extremities) on 10Oct2016 and muscular weakness (upper extremities and lower extremities) on 11Oct2016. It was also reported that on 12Oct2016, the patient visited the hospital and presented a body temperature of around 36 degrees, CRP was 22 mg/dl, WBC was 18000/mm3. The reporting nurse classified all the events as non-serious and assessed vaccination site pain and vaccination site swelling as definitely related and pyrexia as probably related to pneumococcal 13-val conj vac (dipht crm197 protein). The reporting physician classified the events vaccination site pain, vaccination site swelling, myalgia (upper extremities and lower extremities) and muscular weakness (upper extremities and lower extremities) all serious as medically significant and assessed myalgia (upper extremities and lower extremities) and muscular weakness (upper extremities and lower extremities) as probably related to pneumococcal 13-val conj vac (dipht crm197 protein). The patient''s condition was stable. However the events vaccination site pain, vaccination site swelling myalgia and muscular weakness had not yet resolved at time of report. Fever was resolving at time of report. Follow-up (12Oct2016): New information from a contactable physician includes: medical history, concomitant drugs, new events myalgia (upper extremities and lower extremities) and muscular weakness (upper extremities and lower extremities), updated case seriousness, updated events outcome, lab data, reporter causality and seriousness assessment. Sender''s Comments: Based on the information currently available, a causal relationship between the administration of PREVENAR 13 and the occurrence of the reported events cannot be excluded based on the temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

VAERS ID:660152 (history)  Vaccinated:2014-08-06
Age:1.0  Onset:0000-00-00
Gender:Male  Submitted:2016-10-18
Location:Foreign  Entered:2016-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Aluminum compounds
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: DKSA2016SA189218
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPIPV: DTP + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER 2SYRUN
HIBV: HIB (ACTHIB)SANOFI PASTEUR 2SYRUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH 2SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Allergy to metals, Eczema, Injection site erythema, Injection site pruritus, Injection site rash, Scratch, Skin hypertrophy, Skin wound, Vaccination site discolouration, Vaccination site granuloma, Vaccination site reaction
SMQs:, Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Initial unsolicited case received from SPMSD under the reference number- 2016009846. Case received from a lawyer/ Patient insurance (PIC), on 27-Sep-2016. A male patient of unknown age received Act-Hib, (batch number lot not rep, Dose 1) on 14-Nov-2013, Act-Hib, (batch number lot not rep, Dose 2) on 20-Feb-2014, Act-Hib, (batch number lot not rep, Dose 3) on 06-Aug-2014. Other suspect products included: Ditekipol, (batch number Lot not rep, Dose 1) on 14-Nov-2013, Ditekipol (batch number Lot not rep, Dose 2) on 20-Feb-2014, Ditekipol, (batch number Lot not rep, Dose 3) on 06-Aug-2014, Prevenar 13, (batch number Lot not rep, Dose 1) on 14-Nov-2013, Prevenar 13, (batch number Lot not rep, Dose 2) on 20-Feb-2014, Prevenar 13, (batch number Lot not rep, Dose 3) on 06-Aug-2014, Aluminium Compounds, (batch number unknown) on an unknown date. The patient experienced Vaccination site granuloma on both thighs, Itch at vaccination site, Skin wound at vaccination site, Rash on thigh, Discoloration at vaccination site, Eczema, Skin hypertrophy (thickening), Scratch marks at vaccination site and Allergy to aluminum on an unknown date. The parent has sought compensation for the son since he has followed the childhood vaccination program and has developed granuloma on both thighs. The parent reports: That the patient has granuloma on both thighs. That he has itch on the thigh due to the granuloma. That he has rash at vaccination site. That he has discoloration at vaccination site. That he has skin wounds at vaccination site. That he has scratch marks at vaccination site. The parent has attached photos to show scratch marks and discoloration. Due to his problems, the patient has been investigated at GP and dermatologist. PIC has assessed the case based on the report, medical records and other information relevant to the case: It is stated in the medical journal of GP that the patient was vaccinated with Di-Te-KI-Pol/Act-Hib and Prevenar 13 on 14-NOV-2013, 20-FEB-2014 and 06-AUG-2014. The patient was seen by GP and at hospital due to problems with itch and granuloma in the thighs. Between 03dec2015 and 30mar2016 the patient went to the doctor three times due to problems with itch and granuloma in the thighs. In the journal, granuloma and redness on both thighs were described. It was thought to be vaccination granulomas. Due to ongoing problems with itching granuloma, the patient was referred to hospital and was seen on 11 Jul 2016. In the medical journal, a 5 cm area on each thigh with scratched eczema and thickening was described. A patch test was therefore done and on 18 Jul 2016 the results showed aluminum allergy. PIC assessed that the patient is entitled to compensation for the damages. It is PIC''s assessment that the aluminum allergy and granulomas on the patient''s thighs most likely are due to the vaccination with Di-Te-KI-Pol/Act-Hib or Prevenar 13. PIC has emphasized: That both vaccines contain an aluminum-containing adjuvant. That the granuloma, aluminum allergy and itch are known but rare side effects of these vaccines. And that the problems developed in the same region where the vaccines were given. It is PICs assessment that the patient''s eczema is not certainly due to the vaccination with Di-Te-KI-Pol/Act-Hib or Prevenar 13. The patient''s outcome was reported as Unknown. Sender''s Comments: Itching granuloma is not listed after Act-Hib however Act-Hib doesn''t contain any aluminium excipient. It is worth to note that DiTeKipolAct-Hib is a combined vaccine. Thus, the causal relationship with Act-Hib can be ruled out.

VAERS ID:659529 (history)  Vaccinated:2016-05-19
Age:67.0  Onset:2016-05-19, Days after vaccination: 0
Gender:Female  Submitted:2016-10-12, Days after onset: 146
Location:Pennsylvania  Entered:2016-10-17, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: USPFIZERINC2016471212
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHM773391UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Periarthritis, Shoulder operation
SMQs:, Arthritis (narrow)
Write-up: This is a spontaneous report from a contactable medical assistant reporting on behalf of the physician communicated to a Pfizer sales representative. A 67-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot M77339, Expiration Date Jul2017), via an unspecified route of administration, first dose on 06May2016 and second dose on 19May2016, both at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced frozen shoulder on an unspecified date. On 19May2016 patient referred to a Chiropractor to seek a treatment for a frozen shoulder and she was referred to an Orthopedic Surgeon. Therapeutic measures taken as a result of frozen shoulder included surgery. The outcome of the event was unknown.

VAERS ID:659581 (history)  Vaccinated:2016-10-04
Age:85.0  Onset:2016-10-11, Days after vaccination: 7
Gender:Female  Submitted:2016-10-17, Days after onset: 6
Location:Georgia  Entered:2016-10-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Diagnostic Lab Data:
CDC Split Type: USSA2016SA188123
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURUI689AA IMLA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Initial unsolicited report received from a pharmacist on 11 October 2016. This case involves a 85-year-old female patient who was vaccinated with a dose FLUZONE HD via intramuscular route (batch number- UI689AA, expiry date -26 April 2017, dose in series and dose was not reported) in left arm; with a dose of PREVENAR 13 via intramuscular route in right arm (Manufacturer: Pfizer, batch number, expiry date, dose in series and dose were not reported) on 04 October 2016. The patient''s medical history, ongoing illness at the time of vaccination was denied and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as none. Concomitant medications were not reported. On 11 October 2016, 7 day following the vaccination, the patient had experienced large area of redness and soreness at injection site. The previously the patient was vaccinated with FLUZONE HD on 2015 (on an unknown date). Relevant laboratory data and corrective treatment were not reported. The outcome of event was unknown. List of documents held by sender: none.

VAERS ID:659642 (history)  Vaccinated:2016-10-13
Age:66.0  Onset:2016-10-14, Days after vaccination: 1
Gender:Male  Submitted:2016-10-17, Days after onset: 3
Location:Missouri  Entered:2016-10-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pravastatin 40mg daily
Current Illness: Pt woke up the next day 10/14/16 with red cheeks and a hoarse throat.
Preexisting Conditions: NKDA; Medical condtions: Hyperlipdemia, pain
Diagnostic Lab Data: na
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHN349350IMRA
Administered by: Other     Purchased by: Public
Symptoms: Dysphonia, Erythema
SMQs:, Anaphylactic reaction (broad), Parkinson-like events (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt woke up with red cheeks and hoarse throat on 10/14/2016. He contacted his primary doctor via phone and was advised to take Benadryl and go to ER if having difficulty breathing. Patient''s symptoms were resolved after taking Benadryl. Phamacy was notified of ADR on 10/17/16 and all signs and symptoms resolved. Protocol doctor was notified by pharmacy of ADR on 10/17/16.

VAERS ID:659664 (history)  Vaccinated:2016-10-03
Age:1.0  Onset:2016-10-11, Days after vaccination: 8
Gender:Female  Submitted:2016-10-17, Days after onset: 6
Location:Iowa  Entered:2016-10-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cold few weeks prior
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.M0152900IMLL
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.M0048920IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHN165123IMRL
Administered by: Public     Purchased by: Public
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Shots on 10/3/16- had quarter size red area on right leg for 4 days and then it went away. On 10/11/16- developed 2 inch long red area on other injection site on right leg- grandma said is hard, red and getting warmer. No fever and child acting ok. Grandma called doctor office 10/13/16 and they prescribed Benadryl. Grandma called agency the same day and we called state nurse consultant for immunizations. She thought should go in to doctor to check it out. Called grandma back to inform. Called grandma on Monday- 10/17/16 for follow up and stated ended up taking baby in on 10/13/16 to have it checked and was diagnosed with cellulitis. Is on antibiotics and the area is getting smaller as of 10/17/16.

VAERS ID:659725 (history)  Vaccinated:2016-09-06
Age:78.0  Onset:0000-00-00
Gender:Male  Submitted:2016-10-17
Location:Ohio  Entered:2016-10-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOLE; PLAVIX; LOSARTAN; METOPROLOL; SPIRIVA; ALLOPURINOL; INDOMETHACIN; ISORBIDE; TRAMADOL; ATORVASTATIN; ASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial stent insertion; Back pain; Blood pressure; COPD; Gout
Diagnostic Lab Data:
CDC Split Type: USPFIZERINC2016426552
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHL034335 IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Mobility decreased, Pain, Pain in extremity
SMQs:, Parkinson-like events (broad), Tendinopathies and ligament disorders (broad)
Write-up: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A 78-year-old male patient of an unspecified ethnicity received PREVNAR 13 (Batch/Lot #: L034335, expiration date 10May2017) via intramuscular route on the right deltoid at 0.5ml single dose on 06Sep2016 10:30 AM for pneumococcal immunization. Patient medical history included Chronic obstructive pulmonary disease, back pain, gout, blood pressure, heart stent. Concomitant medications included omeprazole 40mg BID, PLAVIX 75mg QD, Losartan 50mg BID, Metoprolol 50mg BID, SPIRIVA 1DF daily for COPD, Allopurinol 300mg QD, Indomethacin as needed for gout, Isorbide 30mg QD, Tramadol for pain 50mg TID, Atorvastatin; for cholesterol 80mg and aspirin 81 mg daily. No other vaccines were administered in the same date. On 02Sep2016 the patient received FLUZONE (Manufacturer: Sanofi Pasteur, Lot# UI637AA) via intramuscular route on the left deltoid. After the vaccination, on an unspecified date in Sep2016, the patient could not move arm and he experienced shooting pain that travelled up the arm. The patient was not admitted to hospital. Outcome was unknown. The vaccine was administered in the pharmacy. Follow-up (11Oct2016): Additional information received from the contactable pharmacist includes age of the patient, Batch/Lot #, prescribed dose, route of administration, time vaccination, anatomical location of the vaccine. Vaccination administered within four weeks prior to date of vaccination. Information on concomitant medications and medical history.

VAERS ID:659726 (history)  Vaccinated:2016-09-29
Age:67.0  Onset:2016-10-07, Days after vaccination: 8
Gender:Female  Submitted:2016-10-17, Days after onset: 10
Location:New Jersey  Entered:2016-10-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none, Comment:
Diagnostic Lab Data:
CDC Split Type: USPFIZERINC2016475920
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT)SANOFI PASTEURUI666AA IMRA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHN16562 IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Peripheral swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This is a spontaneous report obtained from a contactable pharmacist. A 67 year old female patient received, on 29Sep2016, PREVNAR 13, (Lot. N16562, Expiration date: Oct2017, NDC number: 00005197105, UPC number: 30005197105) 0,5 ml, single dose, route of administration unspecified, in the upper arm (deltoid) for immunization. Relevant medical history was none. Concomitant medication included FLUZONE, (Lot. UI666AA, manufacturer: Sanofi Pasteur), received on 29Sep2016, for immunization. On 07Oct2016, the patient experienced swelling and redness in the arm. Clinical outcome of the event was unknown at time of this report. The events were considered related to pneumococcal 13-val conj vac (dipht crm197 protein).

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